Six health insurance companies say they won't cover Biogen's Alzheimer's disease drug, calling it experimental even though it was approved last month by the US Food and Drug Administration, the Boston Globe reports. Additionally, the New York Times writes that at least two major medical centers say they will not administer the drug either.
FDA's approval of aducanumab, or Biogen's Aduhelm, last month was controversial. An FDA advisory panel determined last November that there was not enough data indicating the drug slowed cognitive decline among Alzheimer's disease patients, and the agency's subsequent approval — even though the agency typically follows the advice of its advisors — led a handful of panel members to resign. Additionally, the acting commissioner of the agency, Janet Woodcock, has sought an independent investigation of the drug's approval.
Now, according to the Globe, six Blue Cross and Blue Shield affiliates — in Florida, New York, Michigan, North Carolina, and Pennsylvania — say they will not cover the drug because it is "investigational" or "experimental" or because "a clinical benefit has not been established."
Tufts Medical Center Institute for Clinical Research and Health Policy Studies' James Chambers tells the Globe this is unprecedented for an approved drug.
At the same time, the Times reports that the Cleveland Clinic and the Mount Sinai Health System in New York have also said they will not administer the drug. "Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time," the Cleveland Clinic says in a statement, according to the Times.